• Cyber Letters (updated)
• Medical, Statistical, and Clinical Pharmacology Reviews of Pediatric Studies (updated)
• Natural Disaster Response (updated)
• New and Generic Drug Approvals
  • Galantamine Hydrobromide Tablets, Alphapharm Party, Ltd., Approval
  • Galantamine Hydrobromide Tablets, Barr Laboratories, Inc., Approval
  • Glucophage (metformin hydrochloride) Tablets, Bristol-Myers Squibb Co., Labeling Revision
  • Glucophage XR (metformin hydrochloride) Extended-Release Tablets, Bristol-Myers Squibb Co., Labeling Revision
  • Sandostatin (octreotide acetate) Injection, Novartis Pharmaceuticals Corp., Labeling Revision
  • Zemuron (rocuronium bromide) Injection, Organon USA, Inc., Patient Population Altered

August 28, 2008

• New and Generic Drug Approvals
  • Estring (estradiol) Extended-Release Vaginal Insert, Pharmacia & Upjohn Co., Labeling Revision
  • Invega (paliperidone) Extended-Release Tablets, Johnson & Johnson Pharmaceutical Research & Development, LLC, Manufacturing Change or Addition
  • Metadate CD (methylphenidate hydrochloride) Extended-Release Capsules, UCB, Inc., Labeling Revision
  • NovoLog Mix 50/50 (insulin aspart protamine and insulin aspart) Injectable Suspension, Novo Nordisk, Inc., Approval
  • Radiogardase (Prussian Blue) (ferric hexacyanoferrate(II)) Capsules, Heyl Chemisch-Pharmazeutische Fabrik GmbH & Co., Package Change

August 27, 2008

• Division of Antiviral Products (DAVP) Getting Started with the Pre-IND Process (contact information updated)
• Drugs@FDA Downloadable Data Files (updated)
• Guidance for Industry: Integrated Summary of Effectiveness [PDF] or [HTML]
• New and Generic Drug Approvals
  • Omnitrope (somatropin [rDNA origin] Injection, Sandoz, Inc., Formulation Revision
  • Salonpas Patch (methyl salicylate and menthol), Hisamitsu Pharmaceutical Co., Inc., Package Change
  • Trandolapril Tablets, Dr. Reddy's Laboratories, Ltd., Approval
• Office of Antimicrobial Products (OAP) Pre-IND Consultation Program: Pre-IND Consultation Contact List (updated)

August 26, 2008

• Drug Shortages: Current Drug Shortages; Zanosar (Streptozocin) Injection
• New and Generic Drug Approvals
  • Aloxi (palonosetron hydrochloride) Capsules, Helsinn Healthcare, SA, Approval
  • Monistat 7 (miconazole nitrate) Vaginal Cream, Johnson & Johnson Healthcare Products, Manufacturing Change or Addition
  • Precose (acarbose) Tablets, Bayer HealthCare Pharmaceuticals, Labeling Revision

August 25, 2008

• FDA updates the Information for Healthcare Professionals sheet for Tysabri (natalizumab).
• New and Generic Drug Approvals
  • Amicar (aminocaproic acid) Oral solution, Xanodyne Pharmaceuticals, Inc., Labeling Revision
  • Amicar (aminocaproic acid) Tablets, Xanodyne Pharmaceuticals, Inc., Labeling Revision
  • Ceftriaxone (ceftriaxone sodium) Injection, Bedford Laboratories, Approval
  • Losartan Potassium Tablets, Aurobindo Pharma, Ltd., Tentative Approval
  • Metaglip (glipizide and metformin hydrochloride) Tablets, Bristol-Myers Squibb Co., Labeling Revision
  • Mucinex (guaifenesin) Extended-Release Tablets, Adams Respiratory Therapeutics, Package Change
  • Pamidronate Disodium Injection, Pliva-Lachema, AS, Approval
  • Qvar 40 (beclomethasone dipropionate) Inhalation Aerosol, Teva Global Regulatory Research, LLC, Labeling Revision
  • Qvar 80 (beclomethasone dipropionate) Inhalation Aerosol, Teva Global Regulatory Research, LLC, Labeling Revision
  • Rocephin (ceftriaxone sodium) Injection, HLR Technology Corp., Labeling Revision
  • Rocephin Kit (ceftriaxone sodium and lidocaine) Injection, HLR Technology Corp., Labeling Revision
  • Somavert (pegvisomant) Injection, Pharmacia & Upjohn, Labeling Revision
  • Sustiva (efavirenz) Capsules, Bristol-Myers Squibb Co., Labeling Revision
  • Sustiva (efavirenz) Tablets, Bristol-Myers Squibb Co., Labeling Revision
  • Vidaza (azacitidine) Subcutaneous I.V. Injection, Celgene Corp., Efficacy Supplement with Clinical Data to Support

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August 29, 2008 Federal Register: Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Request for Inspection Under the Inspection by Accredited Persons Program   August 28, 2008 Federal Register: Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval Applications Class I Medical Device Recall: Pacific Consolidated Industries LLC, Mobile Oxygen Storage Tank   August 27, 2008 Summary Information for: Attain StarFix Model 4195 Lead   August 26, 2008 Summary Information for: T-SPOT-TB   August 25, 2008 Federal Register: Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Certification to Accompany Drug, Biological Product, and Device Applications or Submissions (Form FDA 3674) Federal Register: FDA Regulations; Technical Amendment PMA Final Decisions for July 2008

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